Trials / Completed
CompletedNCT02633020
Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Type II Refractory Celiac Disease
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Type II Refractory Celiac Disease, an In Situ Small Bowel T Cell Lymphoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Protocol CELIM-RCD-002 is designed to evaluate the efficacy and safety of AMG 714 for the treatment of adult patients with type II refractory celiac disease (RCD-II), an in-situ small bowel T-cell lymphoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AMG 714 | Administered via a 120-minute IV infusion for a total of 7 times over 10 weeks. |
| BIOLOGICAL | Placebo | Administered via a 120-minute IV infusion for a total of 7 times over 10 weeks. |
Timeline
- Start date
- 2016-04-13
- Primary completion
- 2017-04-11
- Completion
- 2017-05-02
- First posted
- 2015-12-17
- Last updated
- 2019-12-27
- Results posted
- 2019-12-27
Locations
6 sites across 5 countries: United States, Finland, France, Netherlands, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02633020. Inclusion in this directory is not an endorsement.